BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 3140600 · Received May 31, 2013

    Report

    Report Number
    1056600-2013-00032
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 31, 2013
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(4) 2013 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND CHANGED THE SYRINGE THAT HAD CRYSTALLIZATION AROUND IT. THE FE PERFORMED A PM. THE FE CHANGED THE WASH STATION AND SILENCERS AS PART OF THE PM. THE FE ALSO CHANGED THE PROBE AND DID CAMERA ADJUSTMENTS. THE FE DID REFERENCE IMAGE. THE FE RAN DIAGNOSTICS AND ALL PASSED. QC RAN AND VERIFIED BY THE CUSTOMER. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS FALSE POSITIVE REACTIONS IN THE ANTI-D MICROWELL ON A SAMPLE THAT WAS FOUND TO BE RH NEGATIVE WHEN USING MANUAL TUBE. NO ERRONEOUS RESULTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240703 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.2

    Patients

    Seq Age Sex Outcome Treatment
    1